SUNBEAM Phase 3 Trial of Ozanimod in Relapsing Multiple Sclerosis Continues to Enroll According to Plan; Overall Phase 3 Program on Track to be Completed in 1H 2017
Receptos Well Capitalized to Advance Clinical Development Programs
SAN DIEGO, April 1, 2015 (GLOBE NEWSWIRE) — Receptos, Inc. (RCPT) announced today that the Company has completed enrollment in the RADIANCE Phase 3 trial of ozanimod (formerly RPC1063) in patients with Relapsing Multiple Sclerosis (RMS). The trial was over-enrolled by approximately 10% due to strong interest among investigators and patients. The Company is continuing to enroll the SUNBEAM trial of ozanimod in patients with RMS. Receptos is on track to complete this Phase 3 clinical development program in the first half of 2017.
“Completing enrollment of the RADIANCE trial represents another major corporate milestone for Receptos, and positions ozanimod as the potential next-to-market oral agent for the treatment of relapsing multiple sclerosis,” said Faheem Hasnain, President and Chief Executive Officer of Receptos. “Following positive Phase 2 results in ulcerative colitis, we also plan to initiate a Phase 3 program for ozanimod in inflammatory bowel disease in 2015. We believe that ozanimod represents a potential franchise in immunology, and we continue to explore opportunities in other therapeutic indications where there is strong scientific rationale.”
The announcement follows the disclosure in September 2014 of the detailed Phase 2 results of ozanimod in RMS. In that trial, ozanimod met the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring effects on other MRI parameters. The overall safety profile of ozanimod was consistent with the results of prior trials and continues to be differentiated from other oral agents for the treatment of RMS.
The RADIANCE and SUNBEAM Phase 3 trials each are randomized, double-blind studies designed to compare 0.5 mg and 1.0 mg of ozanimod against interferon beta-1a (Avonex(R) in 1,200 patients with RMS. The primary objectives of the RADIANCE and SUNBEAM trials are to assess whether ozanimod is superior to Avonex(R) in reducing the annualized relapse rate in patients after two years of therapy and one year of therapy, respectively. Both trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA.
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